WO2006085331A2 - Procede et appareil d'insertion d'un catheter - Google Patents

Procede et appareil d'insertion d'un catheter Download PDF

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Publication number
WO2006085331A2
WO2006085331A2 PCT/IL2006/000194 IL2006000194W WO2006085331A2 WO 2006085331 A2 WO2006085331 A2 WO 2006085331A2 IL 2006000194 W IL2006000194 W IL 2006000194W WO 2006085331 A2 WO2006085331 A2 WO 2006085331A2
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
sleeve
tube
proximal
insertion system
Prior art date
Application number
PCT/IL2006/000194
Other languages
English (en)
Other versions
WO2006085331A3 (fr
WO2006085331A9 (fr
Inventor
Shai Amisar
Ronen Radomski
Original Assignee
Flexicath Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from IL16686305A external-priority patent/IL166863A/en
Application filed by Flexicath Ltd. filed Critical Flexicath Ltd.
Priority to AU2006213438A priority Critical patent/AU2006213438B2/en
Priority to CA002597398A priority patent/CA2597398A1/fr
Priority to US11/884,140 priority patent/US20080319387A1/en
Priority to EP06711176A priority patent/EP1848478A4/fr
Publication of WO2006085331A2 publication Critical patent/WO2006085331A2/fr
Publication of WO2006085331A3 publication Critical patent/WO2006085331A3/fr
Publication of WO2006085331A9 publication Critical patent/WO2006085331A9/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0111—Aseptic insertion devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M25/0668—Guide tubes splittable, tear apart
    • A61M2025/0675—Introducing-sheath slitters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M25/0668—Guide tubes splittable, tear apart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires

Definitions

  • the present invention relates to intravascular catheter devices . More particularly, the invention relates to methods and apparatuses for facilitating and controlling the insertion of a catheter device .
  • the present procedure includes inserting a hypodermic needle together with a catheter having an in-dwelling cannula into a suitable vein, withdrawing the needle and leaving the in-dwelling cannula in the vein .
  • Such a catheter is typically provided with a suitable closure and various adapter mechanisms to enable the aseptic introduction of fluid medicaments from a hypodermic syringe or from an intravenous drip .
  • US 5, 478 , 326 describe an arterial device for the control of bleeding from a puncture in an artery wall .
  • This device consists of a flexible cannula the size of which is gradually decreased from its access end towards its insertion tip, which enables bleed control by matching the partly inserted cannula to the size of the arterial puncture .
  • US 3 , 757 , 771 describe a sterile inserter apparatus wherein an elongated catheter is adapted to move through the inserter via a sealed and flexible sleeve .
  • the sealing sleeve is secured to a member that is connected to the inserter end after insertion of an in-dwelling cannula .
  • the catheter apparatus described in US 3 , 825 , 001 includes catheter tubing sealed in a flexible plastic sheath having a male fitting secured to its distal end for connecting it to an inserter catheter and a female fitting secured to its proximal end .
  • the male fitting is provided with axial openings to allow insertion of the catheter tubing through the inserter catheter .
  • An intravenous catheter system is described in WO 03/084428.
  • This system comprises a multi-use entry-port element and a flexible catheter tube that is adapted for slidable insertion into a vein through the entry port .
  • the flexible catheter tube is provided in a sterile environment containment element that allows insertion of the catheter tube in a generally non- sterile environment .
  • None of the aforementioned publications provides means for controlling the insertion of the catheter .
  • the insertion of intravenous catheter devices was carried our by grasping the catheter tube via the sterile containment and pushing the catheter tube inwardly into the entry port of the indwelling cannula .
  • the prior art devices do not include control means for controlling the insertion of the catheter tube .
  • the prior art catheter devices do not provide means for preventing accidental withdrawal, or means for preventing the use of excess force that may result in internal injuries .
  • the prior art devices do not provide means for carrying out the requisite procedure with a partially inserted catheter .
  • the present invention is primarily directed to a catheter insertion system comprising, at a first end, a distal entry port, at a second end a proximal section, a sealed catheter sleeve situated between said entry port and said proximal section, and further comprising advancing means for advancing a catheter contained within said system in a distal direction
  • said entry port comprises a hollow body terminating at one end in a hollow cannula suitable for insertion into a peripheral blood vessel and having an internal diameter suitable for permitting passage of an intravascular catheter, and terminating at the other end with a connector element
  • said proximal section comprises a hollow body having at least one external opening permitting the withdrawal and/or addition of fluid from or into the proximal opening of a catheter placed within said proximal section; and wherein said sealed catheter sleeve is sealably connected at one of its ends to either said entry port connector element or to advancing means located between said sleeve and said entry port connector element, said sealed catheter sleeve
  • the aforementioned entry port may also comprise an external opening permitting the withdrawal and/or addition of fluid from or into the proximal opening of a catheter placed within said entry port .
  • proximal is used here to refer to elements of the catheter device which are located in relative proximity to the operator
  • distal is used herein to refer to elements of the catheter device the location of which is relatively distant from the operator .
  • the advancing means comprises the sealed catheter sleeve and a plurality of blades situated in close proximity to the distal end of said sleeve, such that when said sleeve is grasped and advanced in a distal direction, the catheter situated within said sleeve is similarly advanced, and said sleeve is progressively cut by said blades , thereby facilitating its removal from said system.
  • the advancing means comprises a flexible tube situated between the entry port and the sealed catheter sleeve, wherein said tube is adapted to permit an operator to grasp and compress said tube such that the catheter situated therewithin may be advanced in a distal direction .
  • the flexible tube contains corrugations along at least part of its length, such that said corrugations provide increased friction between the operator ' s hand and the catheter tube .
  • the advancing means comprises a rotating wheel mechanism situated between the entry port and the sealed catheter sleeve, such that rotation of an externally-situated thumb wheel causes rotation of one or more internally-situated wheels that cause the catheter to move in a distal or proximal direction .
  • the internally- situated wheels are preferably designed to provide a limited amount of friction between said wheels and said catheter tube, thereby limiting the amount of force applied on the thumb wheel .
  • a sealed separator is utilized for separating the adhered sealing strips , exposing the catheter sealed therein, and advancing it into the entry port .
  • the separator comprises a proximal aperture and retaining members for guiding the catheter sealed in the adhered strips, entering the separator via said proximal aperture, towards an opening . of a passage tube linked to the entry port .
  • the adhered strips are separated in the vicinity of the passage tube opening, advanced along the sides of splitting means , and leave the separator via apertures provided thereon .
  • the catheter is exposed and advanced into said passage tube and therefrom into the entry port .
  • the tips of the separated strips may be adhered outside the separator to allow convenient insertion of the catheter by pulling the adhered tips distally.
  • the present invention is also directed to an advancing mechanism for advancing a sterile catheter in a distal direction, wherein said mechanism comprises a sealed spool containing a sterilized catheter wound around a central axis in a spiral manner, and a distal exit, such that said catheter is rolled in or out via said distal exit by rotations of the spool .
  • the distal exit is connected to an entry port via suitable connector means having an inner passage for advancing the catheter therethrough .
  • the inner lumen of the catheter can be accessed via a catheter port connected to the proximal end of the catheter wound, allowing performance of procedures with a partially inserted catheter .
  • the present invention is directed to a catheter insertion system comprising a flexible sleeve containing a catheter tube, wherein the flexible sleeve has a sealed proximal end, and wherein the distal end of the flexible sleeve comprises a slender passage adapted to allow passage of the catheter tube therethrough while preventing backflow of fluid into the sleeve .
  • the catheter insertion system may further comprise one or more permeable portions provided on the flexible sleeve for allowing gas sterilization of the interior of the flexible sleeve .
  • the proximal end of the flexible sleeve is sealed by a plug having a bore, wherein one end of the bore opens into the interior of the flexible sleeve, and wherein the other end of the bore is covered by a permeable sheet for allowing gas sterilization of the interior of the flexible sleeve .
  • the proximal end of the flexible sleeve is closed by a guide wire stopper element, wherein the guide wire stopper element comprises an aperture suitable for the passage of a guide wire holder connected to the proximal end of a guide wire, and wherein the passage of the guide wire holder into the flexible sleeve can be prevented by rotation of the guide wire holder about the axis of the guide wire .
  • a fastening cap adapted to fit in or over the proximal side of the guide wire stopper element is used for sealing the flexible sleeve, wherein the fastening cap may comprise gripping means adapted to grip the guide wire holder and prevent passage thereof into the flexible sleeve .
  • the slender passage element may be a part of a splittable head sealably fitted into the distal end of the flexible sleeve, wherein the splittable head is constructed such that it can be longitudinally split into two or more parts , thereby facilitating tearing of the flexible sleeve .
  • the splittable head may comprise pins adapted to be engaged in respective apertures provided in the flexible sleeve .
  • the splittable head may further comprise splitting tabs provided on each splittable part thereof .
  • the proximal end of the catheter insertion device may be sealed by a sealing plug comprising a slender passage through which the catheter tube is sealably passed such that its proximal port is external to the sleeve .
  • the catheter insertion system may further comprise a depressible element adapted for advancing the catheter tube contained in the flexible sleeve, wherein the depressible element comprises a flexible inverted "V" structure that is capable of advancing the catheter tube distally when pressed.
  • the present invention is also directed to an adapter for a catheter tube cutter, comprising a hollow connector for connecting a catheter insertion device thereto, a base connected to the hollow connector, and an arm connected to the base opposite to the hollow connector, the arm comprises an aperture inline with an opening of the hollow connector, wherein a gap formed between the connector and the arm is suitable for fitting a catheter tube cutter therein and passing a catheter tube in the hollow interior of the connector via a cutter passage provided in the catheter cutter and the aperture in the arm.
  • Fig. IA is a perspective view of a catheter insertion device of the invention comprising a firm sealing sleeve and small blades ;
  • Fig . 2D is a perspective longitudinal section view of the catheter insertion device shown in Fig . 2A in its
  • Fig 5C is a longitudinal section view of the distal portions of the catheter insertion device shown in Fig .
  • Fig . 7B is a close-up perspective view on the proximal portion of the catheter insertion device shown in Fig .
  • Fig . 7C is a longitudinal section view of the distal portion of a tearable application of the catheter insertion assembly shown in Fig . 7A;
  • Fig . 8B schematically illustrates a cutter adapter according to the invention
  • Fig . 8H is a close-up on the guide wire stopper mechanism shown in Fig . 8F;
  • Fig . 9A illustrates a guide-wire stopper mechanism comprising a fastening cap;
  • Fig . 9D is a rear view of the guide-wire stopper mechanism shown in Fig . 9A;
  • Fig . 9E is a perspective front view of the fastening cap
  • Fig . 1OB is a longitudinal view of the splittable head of the catheter insertion device shown in Fig . 1OA;
  • Fig . HC is a perspective view of the depressible element of the catheter device shown in Figs . HA and HB;
  • Quick Connector 131 can be unscrewed, thereby exposing the Luer opening and providing access to the proximal opening of catheter tube 121.
  • Quick connector 131 and guide wire holder 133 are usually discarded after the insertion of the catheter tube is completed .
  • insertion cannula 111 together with its' indwelling disposable needle (not shown) is inserted into the desired blood vessel, following puncture of the overlying skin and the wall of said vessel by the tip of said needle .
  • the entry port is then secured in place by affixing flexible wings 116 to the skin surface .
  • the needle is removed from entry port 110, and the proximal portion of the device (i . e . sleeve 120 pre-connected to proximal hub 132 is then connected to the proximal end of entry port 110 by means of connector 112.
  • the proximal hub 132 is thus directed distally until the entire sleeve is peeled off and socket 130 receives adapter 113 into its hollow interior, as shown in Fig . ID .
  • the interior of socket 130 comprise a female fitting 138 adapted to fasten the proximal end of sleeve 120 inside socket 130, and to receive adapter 113 and provide a sealed connection between the axial bore 104 of connector 112 and the inner bore (not shown) of proximal hub 132.
  • Aperture 134 ( Fig . IB) at the distal side of socket 130 define an inward annular protrusion 137 that is engaged with the annular groove 106 when the insertion of the catheter tube 121 is completed, thereby providing a sealed connection with connector 112.
  • the length of the sealing sleeve 120 should be determined according to the length of the catheter tube used, and its diameter is generally in the range of 10 to 70 millimeters, and preferably about 25 millimeters .
  • the sealing sleeve 120 is preferably transparent and may be fabricated from Silicone or polyurethane .
  • the thickness of the walls of the sealing sleeve is generally in the range of 0.1 to 2 millimeters, and preferably about 1 millimeter, in order to obtain some rigidity of said sleeve .
  • the length of connector 112 is generally in the range of 5 to 15 millimeters, and preferably about 10 millimeters , its outer diameter is generally in the range of 5 to 15 millimeters, and preferably about 8 millimeters , and its inner diameter is preferably defined according to the parameters of the entry port to be used .
  • Connector 112 is preferably fabricated by inj ection molding techniques from polypropylene, polyethylene, or ABS, materials .
  • the Blades 102 are preferably made from a thin, sharp metal strip the length of which is generally in the range of 1 to 8 millimeters, and preferably about 2 millimeters .
  • the catheter insertion device of the invention generally consists of three portions : a proximal portion comprising the catheter port, a guide wire grip, and a socket for sealably connecting said portion to the distal portion; an intermediate portion comprising a sealed containment including portion of the catheter tube sealed therein, and a distal portion connected to the entry port and comprising means for removing said sealed containment and advancing the portions of exposed catheter tube therethrough into the entry port .
  • the elements of the proximal portion, and the entry port, in the different embodiments of the catheter insertion device of the invention are similar in structure and shape, mutatis mutandis, and therefore they will not be described in details hereinafter .
  • the subcutaneous "over the needle" insertion of the cannula described hereinbefore is similarly performed in all other embodiments of the invention, and therefore will not be described with reference to each embodiment of the invention for the sake of brevity.
  • FIG. 2A-2D Another catheter insertion device 200 of the invention is shown in Figs . 2A-2D .
  • Figs . 2A-2C shows the catheter insertion device 200 prior to its insertion into a blood vessel .
  • This embodiment comprises a sealing sleeve 220 enclosing a proximal hub 232 and a catheter tube 221 disposed therewithin .
  • the distal end of the sealing sleeve 220 is secured to the proximal side of adapter 243 by a clip (e . g . , "U" shaped clip) 242, and the distal side of adapter 243 is attached to the proximal end of a flexible and partially corrugated tube 240.
  • Adapter 243 connects the interiors of sealing sleeve 220 and flexible tube 240 via inner bore 246 (Fig . 2B) formed therewithin .
  • Proximal hub 232 comprise a socket 230 a quick connector 231 (e . g . , Luer lock) , and a guide wire holder 233.
  • the catheter tube 221 passes via the interior of proximal hub 232 and its lumen can be accessed via port 233.
  • Proximal hub 232 further comprises a sleeve clamp 234.
  • the sealing sleeve 220 includes a single opening at the distal end thereof, and the proximal end of sleeve 220 is permanently sealed.
  • the entry port 110 comprises an insertion cannula 111, hub 115, and wings 116 for securing entry port 110 to the body of a treated subj ect .
  • Depressions 241 on lateral sides of flexible tube 240 and adj acent to its proximal end, allows the practitioner to conveniently grasp the lateral sides of catheter tube 221 passing via the interior space 245 ( Fig . 2B) of tube 240.
  • the section adj acent to the distal end of flexible tube 240 comprise annular corrugations 244 for advancing the catheter tube 221 passing therewithin by grasping its lateral sides via depressions 241 and advancing the same in a distal direction with the entire proximal section of the catheter insertion device 200 by applying a forward pressure and thereby reducing the total length of corrugated section 244.
  • Corrugated section 244 serves as a spring for restoring the original length of flexible tube 240, thereby allowing insertion of portions of the catheter tube 221 via forward movements without requiring application of backward movements before insertion of further portions of the catheter 221. Similar operation can be achieved by using other resilient mechanisms , such us springs and/or resilient tubes, or combinations hereof .
  • Fig . 2C shows a longitudinal section view of the distal portion of catheter insertion device 200 comprising flexible tube 240, connector 212 , and adapter 243.
  • Catheter tube 221 is shown passing through passage 246 provided inside adapter 243 , via the interior space 245 of flexible tube 240, via conical passage 217 inside connector 212 , and therefrom into the central bore 140 of entry port 110.
  • the tip of conical passage 217 preferably tightly fits over the outer surface of catheter tube 221 in order to prevent blood from flowing via entry port 110 into flexible tube 240.
  • Adapter 243 comprises cylindrical sections at its proximal and distal sides , wherein the cylindrical section at the distal side comprise annular groove 248 that receives an inward annular protrusion at the proximal end of flexible tube 240, and wherein the cylindrical section at the proximal side comprise an annular groove 249 adapted to receive the distal end of sealing sleeve 220, which is securely sealed thereto by clip 242 , and an inward annular protrusion 137 at the distal side of socket 230.
  • an additional annular groove may be provided proximally adj acent to groove 249 for receiving the annular protrusion of socket 230. In this way a sealed passage is defined for advancing the catheter tube 221 starting from the interior of sleeve 220 via the interior space 245 of flexible tube 240 and through the central bore 140 of entry port 110.
  • Connector 212 consists of a cylindrical hollow member 211 having an opening 213 at a distal side thereof, wherein the diameter of opening 213 is greater than the outer diameter of the proximal end of entry port 110, thereby allowing insertion of the proximal end of entry port 110 into the interior of connector 212.
  • the conical passage 217 inside connector 212 extends outwardly via opening 213 , such that its distal end leaves the interior of cylindrical hollow member 211.
  • the diameter of the distal end of conical passage 217 is smaller than the diameter of the opening at the proximal end of entry- port 110 thereby providing secure sealing therebetween by fitting the proximal end of entry port 110 a round the distal end of conical passage 217.
  • Connector 212 comprises a cylindrical section at its proximal side, where said cylindrical section includes an annular groove 218 which receives the inward annular protrusion 137 at the distal end of flexible tube 240.
  • the catheter tube 221 is not required, such that it may be produced from a type of transparent plastic silicon or from Polyethylene .
  • the catheter tube 221 is slidably inserted via the insertion cannula 111 into the blood vessel by grasping its lateral sides via depressions 241 and forwardly pushing it toward entry port 110, thereby reducing the total length of the corrugated section 244 and moving portions of catheter tube
  • the inner diameter of conical passage 217 at its distal tip approaches the outer diameter of catheter tube 221 for tightly fitting it around the outer surface of catheter 221, in order to provide a grip of catheter tube 221 for preventing its withdrawal after the applied grasp of depressions 241 is released .
  • the corrugated section 244 expands backwardly and restores its previous shape, thereby sliding depressions 241 and adapter 243 backwardly over catheter tube 221.
  • annular groove 249 which provides a sealed and secured connection therebetween .
  • the sealing sleeve 220 can be removed by detaching clip 242 from annular groove 249. After the sealing sleeve 220 is removed the requisite procedure can be carried out .
  • the length of adapter 243 is generally in the range of 8 to 20 millimeters, and preferably about 12 millimeters . Its diameter is preferably in the range of 5 to 15 millimeters , and preferably about 8 millimeters .
  • Adapter 243 is preferably made of polypropylene, polyethylene, or Teflon .
  • the length of the cylindrical sections at the proximal and distal sides of adapter 243 is generally in the range of 4 to 12 millimeters , and preferably about 8 millimeters, and the diameter of annular groove 249 is determined according to the diameter of the sealing sleeve for providing sealed connection therewith, and the diameter of annular groove 248 is determined to provide sealed closing according to the diameter of flexible tube 240.
  • Flexible tube 240 is preferably made of flexible, "memory" type of material (i . e . , capable of restoring its original shape) such as Silicone, and manufactured utilizing known techniques , such as inj ection molding . Its length is generally in the range of 15 to 40 millimeters , and preferably about 25 millimeters, and its diameter is generally in the range of 8 to 20 millimeters , and preferably about 15 millimeters .
  • the dimensions of connector 212 are generally similar to the dimensions of connector 112 , and accordingly the dimensions of the conical passage 217 should be determined according to the entry port 110 used .
  • Clip 242 is preferably made from a type of flexible hard material such as polypropylene, or stainless steel .
  • An advancing mechanism 350 can be used for advancing the catheter tube 321, as shown in Figs . 3A to 3D .
  • the catheter insertion device 300 in this embodiment comprises a proximal hub 232 and catheter tube 231 enclosed within sealing sleeve 220, advancing mechanism 350, and a hollow connector 312 connecting the interior of advancing mechanism 350 with the central bore (140 shown in Fig. 1C) of entry port 110.
  • the opening at the distal end of the sleeve 220 is sealed by clip 342 placed over its edge and fastening it over an annular groove 355 ( Fig . 3B) provided at the proximal end of advancing mechanism 350.
  • Advancing mechanism 350 comprises cylindrical sections, 352 (comprising annular groove 355) - at its proximal end and 354 - at its distal end, a sealing cover 351 ( Fig . 1 ) , and an applicator wheel 353.
  • Axial bores , 352a and 354a, ( Fig . 3B) are provided inside cylindrical sections 352 and 354, respectively.
  • Cylindrical section 352 is adapted to be received inside socket 230 and comprises an annular groove adapted to receive clip 342 while grasping the edge of sleeve 220 over it .
  • Said annular groove is also adapted to receive an inward annular protrusion 137 at the distal side of socket 230.
  • an additional annular groove may be provided for receiving said inward annular protrusion 137 at the distal side of socket 330.
  • a sealed passage is provided for advancing catheter tube 321 from the sealing sleeve 220 via advancing mechanism 350 utilizing the axial bores, 352a and 354a, of cylindrical sections 352 and 354, and through central bore of entry port 110.
  • Fig . 3D is a close-up on the inner elements of advancing mechanism 350.
  • the container enclosing the elements of advancing mechanism 350 is not shown in Fig . 3F.
  • Applicator 353 is attached to wheel 357b via upper end of shaft 358b .
  • Shaft 358b passes vertically via the axial center of wheel 357b and leaves the interior of advancing mechanism 350 via an aperture in sealing cover 351.
  • the upper tip of shaft 358b is received inside a central bore in applicator 353.
  • Wheel 357a is situated adj acent to wheel 357b, and the vertical shaft 358a passing through its axial center is parallel to shaft 358b .
  • Fig . 3E illustrates the catheter insertion device 300 in the inserted state .
  • socket 230 receives into its interior the proximal cylindrical section 352 of advancing mechanism 350 , and male fitting 238 ( Fig . 3C) inside socket 230 is received in the respective female fitting provided in cylindrical section 352 , thereby provide a sealed connection between the interior space of advancing mechanism 350 and the inner bore (not shown) of proximal hub 232.
  • a sealed connection is obtained therebetween by engaging an inward inner protrusion 137 defined by the opening at the distal side of socket 230 with the annular groove 355 provided on the cylindrical section 352.
  • Cover 351 is preferably made from the same type of material and its sizes are determined according to the dimensions of container 350.
  • Wheels 357a and 357b are preferably made from a type of polymer, such as polypropylene, Teflon, or ABS, and their diameters are generally in the range of 8 to 20 millimeters, and preferably about 12 millimeters .
  • the vertical length of shaft 358 is determined according to the height of the container of mechanism 350. Shaft 358b is slightly prolonged in order to receive applicator at its upper end.
  • the diameter of applicator 353 is generally in the range of 10 to 30 millimeters, and preferably about 18 millimeters .
  • the sealing strip bilayer 460 is inserted into advancing mechanism 450 via a slender vertical passage provided along a cylindrical section 452 at the proximal end of advancing mechanism 450.
  • the catheter tube 421 is separated from the sealing strip bilayer 460 and further advanced via an axial bore provided in a cylindrical section 454 at the distal end of advancing mechanism 450.
  • the catheter tube 421 is advanced into the central bore (140, Fig . 4C) of entry- port 110, via an inner passage provided inside connector 412.
  • Figs . 4D and 4E show the elements of the advancing mechanism 450, and other elements attached thereto .
  • the advancing mechanism 450 comprise two adj acently disposed winding wheels , 457a and 457b, each of which consists of a hollow cylindrical member for winding the respective strips 460a and 460b thereon, a gear wheel at one side of the cylindrical member and a guard wheel at the other side of said cylindrical member .
  • the winding wheels 457a and 457b are attached at their guard wheel side by pivot protrusions 459 to the inner bottom side of the container such that their cylindrical members are substantially parallel .
  • winding wheel 457a is attached at the gear wheel side to the cover 451.
  • Winding wheels 457a and 457b can freely rotate over pivot protrusions 459, and the teeth of their gear wheels are engaged such that rotation of one of said wheels is induced by the gear wheels to the other wheel .
  • Shaft 455 attached to the axial center of winding wheel 457b passes via an aperture in cover 451 and received in a respective bore at the center of the applicator wheel 453.
  • Two adhered sealing strips 460a and 460b enclose the catheter tube 421 therewithin .
  • the distal ends of said strips are attached to cylindrical members of the winding wheels 457a and 457b, respectively.
  • applicator wheel 453 thereby rotates the winding wheels 457a and 457b .
  • the adhered strips 460a and 460b are separated and wound around the respective winding wheel, thereby exposing the catheter tube enclosed therein and advancing it toward passage tube 417.
  • Strips 460 may be adhered utilizing a high tack glue (i . e . , having high degree of stickiness ) , but of a low strength, thereby enabling the operator to retract the portions of the inserted catheter tube and sealing it back inside strips 460 as it is pulled out . Such action may be required when the catheter is stuck and there is a need to retract a portion thereof in order to further advance it in a forward direction .
  • a high tack glue i . e . , having high degree of stickiness
  • retaining members 458a and 458b are perpendicularly situated on the bottom side of the container of advancing mechanism 450 near the inner opening of the slender passage provided in cylindrical section 452.
  • the sealing strip bilayer 460 passes between the retaining members 458a and 458b, which directs it towards the passage tube 417.
  • winding wheel 457a is not depicted in the advancing mechanism shown in Fig . 4F.
  • the splittable introducer 761 may be splitted and discarded by pulling tabs 768.
  • the entire length of catheter tube 751 is advanced into the patient and the tapering end of catheter port 757 ( Fig . 7A) is fitted into cavity 771 (Fig . 7D) provided at the proximal end of slender passage element 752.
  • a modified catheter insertion device 770 which may be teared away.
  • tearing tab 766 is preferably provided at the distal end portion of sleeve 760, perpendicularly protruding therefrom between parallel tear lines 769 provided along the longitudinal length of sleeve 760.
  • the flexible sleeve 760 of the catheter insertion device 750 can be ripped and discarded, after completing the insertion of the catheter tube 751, by pulling upwardly tearing tab 766, as demonstrated in Fig . 7E .
  • proximal end of guide wire 829 is attached to the sealed proximal end of sleeve 817 for preventing it from being advanced into the inner space of catheter tube cutter 50, thereby preventing the situation wherein its distal portion is cut .
  • Fig . 8F is a close-up on the rear portion of the catheter insertion device shown in Fig . 8A which comprise a guide-wire stopper mechanism 808.
  • the proximal end of sleeve 817 terminates in a guide wire stopper 808 comprising a rigid partition 825 which close the proximal end of sleeve 817 while allowing it to hold guide wire holder 821 provided at the proximal end of guide wire 829.
  • Aperture 820 may be provided in partition 825 through which guide wire holder 821 can be passed proximally out of sleeve 817.
  • Aperture 820 and guide wire holder 821 can be configured in a plurality of shapes (e . g . , curved, triangular, "X" , waved) for preventing distally longitudinal movements of guide wire 829 by rotating guide wire holder 821 about the longitudinal axis of guide wire 829 after passing it through aperture 820.
  • Guide wire stopper 808 may be implemented by a hollow cylindrical element comprising a partition 825 thereinside which defines an external compartment 827 in which guide wire holder 821 can be fixtured, as demonstrated in Fig . 8F.
  • Said external compartment 827 ( Fig . 8G) may be sealed by a suitable cap 826 which may be fastened thereover by the aid of one or more flexible fasteners 823 provided on the external surface of stopper 808.
  • Cap 826 may further contain a permeable section permeable to gases for allowing sterilization of the inner space of sleeve 817.
  • portions of catheter tube are advanced distally out of sleeve 817 while respective portions of guide wire 829 are retracted from the catheter tube via catheter port 807.
  • guide wire stopper 900 is designed to received a fastening cap 924 into an external compartment 925 provided therein .
  • Fastening cap 924 is further configured to grip the guide holder ( Fig . 9E) and thereby prevent accidental rotation and release thereof during the trimming process .
  • Guide wire stopper 900 may be implemented as a hollow cylindrical element having sealing threads 911 on the outer surface of a distal portion thereof adapted to be inserted into sleeve 901 of a catheter insertion device of the invention .
  • Guide wire holder may further comprise a proximal flange 910 for preventing it from being pressed into sleeve 901.
  • Fastening cap 924 further comprise an actuating tab 921 ( Fig . 9C) and griping means provided in its hollow interior, for griping guide wire holder (not shown) .
  • An external groove 923 may be provided on the outer surface of fastening cap 924 near its distal rim 922 for locking it into guide wire stopper 900.
  • guide wire stopper 900 has a hollow cylindrical shape and its interior may be accessed via the proximal opening 927 or via aperture 920 provided in its distal side wall 925.
  • Aperture 920 is configure to enable passage of a guide wire holder therethrough and fixture thereof by rotation, as was described herein above with reference to Figs . 8F to 8H .
  • Proximal opening 927 may be sealed by fastening cap 924 by fitting said cap into the internal space of guide wire stopper 900, and sliding inner protrusions 926 provided in stopper 900 into the external groove 923 of fastening cap 924.
  • the inner diameter of guide wire stopper 900 is generally in the range of 6 to 30 mm, preferably about 20 mm, and its length is generally in the range of 5 to 30 mm, preferably about 20 mm.
  • the outer diameter of fastening cap 924 is configured to allow tight fitting it into guide wire stopper 900, its inner diameter is generally in the range of 5 to 25 mm, preferably about 10 mm, and its length is generally in the range of 5 to 25 mm, preferably about 15 mm.
  • a catheter insertion device 930 of the invention having a splittable head 932 is shown in Fig . 1OA.
  • Catheter insertion device 930 comprises a flexible sleeve 936 comprising a distal resilient portion 931 and which distal end is sealed by a splittable head 932.
  • Flexible sleeve 936 may be manufactured from a single continuous sleeve, or alternatively, from two separate sleeves , 936a and 936b.
  • Fig . 1OB shows a longitudinal section view of splittable head 932.
  • splittable head 932 is assembled from two connectable parts, 932a and 932b, each of which comprises a respective splitting tab 941, lateral pin 942 , and cross- sectional portions of cylindrical main body 933 and quick connector 943.
  • the hollow interiors of cylindrical main body 933 and of quick connector 943 are connecter via slender passage element 937.
  • Slender passage element 937 is configured to allow the passage of catheter tube 801 therethrough while preventing backflow of fluids such as blood into sleeve 936.
  • Slender passage element 937 may be an integrated part of splittable head 932 such that each connectable part thereof, 932a and 932b, comprises a portion thereof, or alternatively, it may be a separate element attached to the inner wall of quick connector 943.
  • Splittable head 932 may manufactured by inj ection molding from a rigid type of material, preferably from polypropylene, its diameter is generally in the range of 8 to 25 mm, preferably about 15 mm, its length is generally in the range of 10 to 35 mm, preferably about 15 mm.
  • Splitting tabs 941 are preferably an integral part of splittable head 932, their lateral length is generally in the range of 5 to 20 mm, preferably about 10 mm, and they may have a tapering shape as demonstrated in Fig . 1OA.
  • FIG. HA Another catheter insertion device 150 of the invention is schematically illustrated in Fig . HA.
  • a depressible element 152 is utilized for advancing catheter tube 162 passing inside elastic sleeve 160.
  • Elastic sleeve 160 is sealed at its proximal end 153 and comprise a slender passage element 158 and an adapter 157 fitted in its distal end.
  • the inner surface portion near the distal end of sleeve 160 is tightly fitted around the outer surface of adapter 157 and the tapering distal end of slender passage element 158 is tightly fitted into a concentric bore of adapter 157, thereby sealing the distal opening of sleeve 160 and providing an opening 156 through which catheter tube 162 may be advanced distally.
  • apex of said "v" shaped member protrudes upwardly via an opening at the upper wall of sleeve 160 which is sealed by a flexible cupola shaped member 151 comprising said apex therein .
  • Arms 152d are placed beside the proximal side of elevated section 159.
  • Adapter 157 is preferably made from a rigid material, such as polypropylene, its length is generally in the range of 8 to 30 mm, preferably about 15 mm, its outer diameter is generally in the range of 2 to 30 mm, preferably about 15 mm, and the diameter of its concentric bore is generally in the range of 3 to 10 mm, preferably about 4 mm.
  • Depressible element 152 may be manufactured from a flexible material, such as polypropylene, the length of its inverted elongated "U” shaped member is generally in the range of 5 to 80 mm, preferably about 10 mm, and the height of arms 152d is generally in the range of 5 to 50 mm, preferably about 20 mm.
  • the length of the legs 152b and 152c of inverted "v" shaped member is generally in the . range of 5 to 40 mm, preferably about 15 mm.
  • Fig. 13A schematically illustrates a catheter insertion device 950 of the invention containing catheter tube 801, wherein catheter port 902 passes via a tight aperture 959 provided in the plug 952 sealing the rear opening of rigid sleeve 936b. This configuration allows accessing the catheter lumen by by removing sealing cap 957.
  • Fig . 13C demonstrates insertion devices 950 ' and 960 ' similar to those shown in Figs . 13A and 13B, and which are configured to allow threading catheter tube 801 contained in insertion device 960 ' over guide wire 963 contained in catheter insertion device 950 ' .
  • catheter insertion device 950 ' is provided with hollow connector 966 configured to receive the tip of distal exit port 964 and thereby provide a sealed connection between the interior of catheter insertion device 950 ' and of insertion device 960 ' .

Abstract

La présente invention porte sur des systèmes et des procédés d'insertion d'un cathéter dans un organe d'un sujet, ce système d'insertion de cathéter comprenant généralement un manchon flexible contenant un tube et un dispositif pour faire avancer le cathéter du système dans une direction distale. Le manchon flexible comporte une extrémité proximale étanche et une extrémité distale pouvant comporter un passage étroit adapté au passage du tube du cathéter tout en empêchant le refoulement du fluide dans le manchon flexible.
PCT/IL2006/000194 2005-02-14 2006-02-14 Procede et appareil d'insertion d'un catheter WO2006085331A2 (fr)

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Application Number Priority Date Filing Date Title
AU2006213438A AU2006213438B2 (en) 2005-02-14 2006-02-14 Method and apparatus for inserting a catheter device
CA002597398A CA2597398A1 (fr) 2005-02-14 2006-02-14 Procede et appareil d'insertion d'un catheter
US11/884,140 US20080319387A1 (en) 2005-02-14 2006-02-14 Method and Apparatus for Inserting a Catheter Device
EP06711176A EP1848478A4 (fr) 2005-02-14 2006-02-14 Procede et appareil d'insertion d'un catheter

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IL16686305A IL166863A (en) 2005-02-14 2005-02-14 Apparatus for inserting a catheter device
IL166863 2005-02-14
US73375905P 2005-11-07 2005-11-07
US60/733,759 2005-11-07

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WO2006085331A2 true WO2006085331A2 (fr) 2006-08-17
WO2006085331A3 WO2006085331A3 (fr) 2007-03-01
WO2006085331A9 WO2006085331A9 (fr) 2013-05-02

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EP (1) EP1848478A4 (fr)
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EP1848478A4 (fr) 2012-10-31
US20080319387A1 (en) 2008-12-25
CA2597398A1 (fr) 2006-08-17
WO2006085331A3 (fr) 2007-03-01
WO2006085331A9 (fr) 2013-05-02
AU2006213438A1 (en) 2006-08-17
EP1848478A2 (fr) 2007-10-31
AU2006213438B2 (en) 2012-04-26

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